PROBEAT-CR— 510(k) K191801

Substantially Equivalent

Hitachi , Ltd.

FDA 510(k) clearance K191801 for PROBEAT-CR, Substantially Equivalent on 2019-09-13. Applicant: Hitachi , Ltd..

Clearance details

Applicant: Hitachi , Ltd.
Product code: Code LHN
Advisory panel: Radiology
Date received: 2019-07-03
Decision date: 2019-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hitachi-Shi, JP

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